MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-15 for CLASSIC PLUS(R) STERNAL NEEDLE HOLDER 36-2025 manufactured by Symmetry Surgical Inc..
[27588462]
Needle insert came apart and fell inside the patient. No harm to the patient. The needle holder inserts were inspected on devices from all lots in inventory. There were no issues with the inserts found. This device was manufactured in (b)(6) 2011. The inserts were repaired under warranty. The device is being repaired and returned to the customer under warranty.
Patient Sequence No: 1, Text Type: N, H10
[27588463]
Needle insert came apart and fell inside the patient. No harm to patient. Device was manufactured in (b)(6) 2011. The inserts were repaired under warranty in (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2015-00020 |
| MDR Report Key | 5100896 |
| Date Received | 2015-09-15 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-08-03 |
| Date Facility Aware | 2015-08-03 |
| Date Mfgr Received | 2015-08-03 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2015-09-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC. |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLASSIC PLUS(R) STERNAL NEEDLE HOLDER |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2015-09-15 |
| Model Number | 36-2025 |
| Catalog Number | 36-2025 |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-15 |